URASSIST— 510(k) K062061
Substantially EquivalentPreferred Medical Devices, Inc.
FDA 510(k) clearance K062061 for URASSIST, Substantially Equivalent on 2006-10-05. Applicant: Preferred Medical Devices, Inc.. Device class: 1.
Clearance details
- Applicant
- Preferred Medical Devices, Inc.
- Product code
- Code NZU
- Device class
- Class 1
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kittery, ME, US
Adverse events under product code NZU
product code NZU- Death
- 11
- Injury
- 1,672
- Malfunction
- 1,452
- Other
- 1
- Total
- 3,136
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.